Initial Dosing
Initiate the dosing regimen for each patient individually, taking into
account the patient's prior analgesic treatment experience and risk
factors for addiction, abuse, and misuse. Monitor patients closely for
respiratory depression, especially within the first 24–72 hours of
initiating therapy with Butrans. Butrans should be prescribed only by
healthcare professionals who are knowledgeable in the use of potent
opioids for the management of chronic pain.
Butrans doses of 7.5, 10, 15, and 20 mcg/hour are for
opioid-experienced patients only.
Butrans is for transdermal use (on intact skin) only. Each Butrans
patch is intended to be worn for 7 days.
Instruct patients not to use Butrans if the pouch seal is broken or
the patch is cut, damaged, or changed in any way and not to cut
Butrans.
Discontinue all other around-the-clock opioid drugs when Butrans
therapy is initiated.
Select an opioid medication*:
*Patients using fentanyl transdermal system or extended-release
hydromorphone for pain control were excluded from the pivotal Butrans
clinical trial with opioid-experienced patients whose opioid daily
dose prior to enrollment was between 30 and 80 mg morphine
equivalents.